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Research progress of - bireociclib - a new cyclin-dependent kinase 4 and 6 inhibitor
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Pan ZHAO, Hui-min ZHOU, Bo CHEN, Feng WANG, Jia-kui LI, Xi-feng MA
Chinese Journal of Clinical Pharmacology | 2025, 41(8) : 1180 - 1185
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Chinese Journal of Clinical Pharmacology | 2025, 41(8): 1180-1185
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Research progress of - bireociclib - a new cyclin-dependent kinase 4 and 6 inhibitor
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Pan ZHAO, Hui-min ZHOU, Bo CHEN, Feng WANG, Jia-kui LI, Xi-feng MA
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  • Preclinical Research and Development Department, Xuanzhu Biopharmaceutical Co., Ltd., Beijing 100025, China
Published: 2025-04-28 doi: 10.13699/j.cnki.1001-6821.2025.08.023
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Bireociclib, a novel selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, demonstrates significant therapeutic benefits in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. As a monotherapy in later-line treatment, it substantially improves objective response rate (ORR), prolongs median progression-free survival (PFS), and extends median overall survival (OS). When combined with fulvestrant as a second-line therapy, it significantly delays disease progression and reduces mortality risk. Currently, marketing authorization applications for Bireociclib monotherapy in breast cancer and its combination with fulvestrant for advanced breast cancer have been submitted to National Medical Products Administration. The phase Ⅲ clinical trial investigating its first-line use in combination with letrozole/anastrozole is nearing completion. This article comprehensively reviews Bireociclib’s molecular structure, pharmacodynamic properties, pharmacokinetic characteristics, etc.

bireociclib  /  cyclin-dependent kinase 4/6 inhibitor  /  breast cancer  /  pharmacology  /  clinical study
Pan ZHAO, Hui-min ZHOU, Bo CHEN, Feng WANG, Jia-kui LI, Xi-feng MA. Research progress of - bireociclib - a new cyclin-dependent kinase 4 and 6 inhibitor[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (8) : 1180 -1185 . DOI: 10.13699/j.cnki.1001-6821.2025.08.023
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doi: 10.13699/j.cnki.1001-6821.2025.08.023
  • Receive Date：2024-10-10
  • Online Date：2026-08-04
  • Published：2025-04-28
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  • Received：2024-10-10
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    Preclinical Research and Development Department, Xuanzhu Biopharmaceutical Co., Ltd., Beijing 100025, China
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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